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OpenTrials
Completed

NCT Number: NCT03582410

Different Types of Suture for Sacral Colpopexy

This randomized controlled study is designed to test absorbable suture compared to non absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction of the patient and rate of mesh erosion.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ospedale regionale Miulli

Acquaviva delle Fonti, Bari, 70021, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion criteria

  • Age > 75 years
  • Severe cardiovascular or respiratory disease
  • Pregnancy

Treatment and study plan

laparoscopic sacral colpopexy with absorbable suture

Procedure

laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture

laparoscopic sacral colpopexy with non absorbable suture

Procedure

laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture

Primary outcomes

  1. Number of patients with anatomical correction of the prolapse

    Time frame: 1 year

    Anatomical correction of the prolapse evaluated by gynecological visit

Secondary outcomes

  1. rate mesh erosion

    Time frame: 1 year

  2. long term outcomes

    Time frame: 1 year

    development of nicturia, dysuria, obstructed defecation , urinary incontinence

  3. Rate of recurrence

    Time frame: 1 year

    de novo anterior or central or posterior compartment prolapse

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

  • Miulli General Hospital

Registry information

Official study title

Absorbable vs Non-absorbable Suture in Laparoscopic Sacral Colpopexy: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2018
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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